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Getinge Maquet Orchide Instructions For Use Manual
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Getinge Maquet Orchide Instructions For Use Manual

Getinge Maquet Orchide Instructions For Use Manual

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Instructions for use
Maquet Orchide
IFU 04661 EN 04 2024-09-27

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Summary of Contents for Getinge Maquet Orchide

  • Page 1 Instructions for use Maquet Orchide IFU 04661 EN 04 2024-09-27...
  • Page 2 © Copyright 2023 Maquet SAS Subject to technical changes. The illustrations and technical specifications provided in this manual may, on account of future product devel- opments, differ slightly from the actual product supplied. V04 27.09.2024 Maquet Orchide IFU 04661 EN 04...

  • Page 3: Table Of Contents

    1.14 Instructions for reducing the environmental impact ................Safety-related information..................16 Environmental conditions ........................Safety instructions ..........................2.2.1 Safe use of the product......................16 Control interfaces ....................18 Use..........................20 Daily inspections before use......................... Maquet Orchide 3 / 50 IFU 04661 EN 04...
  • Page 4 Contact ..............................Technical specifications..................44 Electrical specifications of cameras and receivers ................Other characteristics..........................EMC declaration ........................... Waste management ....................49 Disposal of packaging .......................... Product ..............................Electrical and electronic components ....................Maquet Orchide 4 / 50 IFU 04661 EN 04...

  • Page 5: Introduction

    The product must not be modified in any way without the prior written consent of Getinge. Compliant use of the device Getinge may not be held liable for any direct or indirect damage that results from actions not set out in this user’s manual.

  • Page 6: Information About This Document

    Ø The changes are saved and the Favourites menu is displayed. 1.4.2.5 Hazard levels The text in safety instructions describes types of risk and how to avoid them. Safety instructions are classified into the following three levels: Maquet Orchide 6 / 50 IFU 04661 EN 04...

  • Page 7: Indications

    • In countries where certification is required to exercise a medico-technical profession, person- nel must hold the necessary authorisation in order to be considered as qualified. Maquet Orchide 7 / 50 IFU 04661 EN 04...

  • Page 8: Symbols On The Product And Packaging

    Symbols on the product and packaging Product overview Fig. 1: Maquet Orchide cameras OTICE The camera is designed to capture a perioperative view, which may be shared, saved or broadcast. It is not intended to be used for assistance during an operation or to establish a diagnosis.

  • Page 9: Components

    "VP4K" (4K). If the camera is installed on a lighthead that is not pre-wired for video, the camera will be detected and can be turned on, but no viewing of the video will be possible. Maquet Orchide 9 / 50 IFU 04661 EN 04...
  • Page 10 Fig. 4: E-Pan Tilt feature The E-Pan Tilt function allows the user to focus on a region of interest, and move that area, without having to move the light or the camera. Maquet Orchide 10 / 50 IFU 04661 EN 04...

  • Page 11: Camera With Wireless Video System (Only On Volista)

    1.6.2 Accessories Illustration Description Part num- STG PSX VZ sterilisable handle STG PSX This handle is compatible with all cameras. VZ 01 Tab. 4: Maquet Orchide accessories table Maquet Orchide 11 / 50 IFU 04661 EN 04...

  • Page 12: Device Identification Label

    Device identification label MAQUET SAS Made in France Parc de Limère Avenue de la Pomme de Pin 45074 Orléans Cedex 2 - France YYYY-MM-DD (XX)XXXXXXXXXXXXXX(XX)XXXXXX(XX)XXXXXX(XXX)ARDXXXXXXXXX(XX)XXXXXXXX Maquet Orchide ARDXXXXXXXXX XXXXXX OHDII FHD XXXXXXXX 20-28V 15W max Fig. 6: Product identification label 1 Product name...
  • Page 13 Title 21--Food And Drugs Chapter I--Food and Drug Administration Department of Health and Human Services Subchapter H -- Medical Devices PART 820 - Quality System Regulation Tab. 6: Compliance with quality management standards Maquet Orchide 13 / 50 IFU 04661 EN 04...

  • Page 14: Information Relating To Intended Use

    The Maquet Orchide product range is designed to capture a view of the surgical site. 1.9.2 Indications The Maquet Orchide range is intended to be used for any type of surgery or treatment for which activities on the surgical site must be recorded. 1.9.3 Intended users •...

  • Page 15: Contraindications

    This product does not have any contraindications. 1.10 Primary purpose The primary purpose of the Maquet Orchide range of cameras is to capture a view of the surgical site, while being compatible with the illumination intensity of the surgical lights. 1.11 Clinical benefit Maquet Orchide cameras are medical devices.

  • Page 16: Safety-Related Information

    Anyone not trained in installation, maintenance or decommissioning opera- tions is exposed to the risk of injury or electric shock. Installation, maintenance and decommissioning of the device or components of the device must be performed by a Getinge technician or a Getinge-trained service technician. AR NI NG Risk of burns Certain parts of the device remain hot after use.
  • Page 17 Risk of injury/infection The use of a damaged device may lead to a risk of injury for users or a risk of infection for patients. Do not use a damaged device. Maquet Orchide 17 / 50 IFU 04661 EN 04...

  • Page 18: Control Interfaces

    Control interfaces Control interfaces Fig. 7: Maquet PowerLED II control interfaces Lighthead control keypad Wall-mounted control keypad (optional) Touchscreen control panel (optional) Maquet Orchide 18 / 50 IFU 04661 EN 04...
  • Page 19 Control interfaces Fig. 8: Volista control interfaces Lighthead control keypad Wall-mounted control keypad (optional) Touchscreen control panel (optional) Maquet Orchide 19 / 50 IFU 04661 EN 04...

  • Page 20: Use

    Integrity of sterilisable handles 1. After sterilisation, check that there are no cracks or soiling on the handle. 2. Also after sterilisation, check that the lock- ing mechanism operates correctly. Fig. 10: Sterilisable handles Maquet Orchide 20 / 50 IFU 04661 EN 04...

  • Page 21: Installing/Removing A Ql Camera On A Volista Lighthead

    Pre-positioning prior to installation On the camera Fig. 11: Pre-positioning the camera 1. Rotate the baseplate to align with the tip and form a green arrow Ø The camera is ready to be positioned. Maquet Orchide 21 / 50 IFU 04661 EN 04...

  • Page 22: Fitting The Device To The Lighthead

    Fig. 13: Positioning the lighthead Fig. 14: Instructions for installing the Quick Lock system 1. Present the camera with the pin opposite the slot 2. Place the two arrows opposite each other. Maquet Orchide 22 / 50 IFU 04661 EN 04...

  • Page 23: Removing The Device

    2. Keep the button pressed and, using two hands, rotate the base of the device anticlockwise. 3. Remove the Quick Lock camera by pulling upwards Ø The device is removed. Fig. 17: Removing the lighthead Maquet Orchide 23 / 50 IFU 04661 EN 04...

  • Page 24: Installing/Removing A Ql+ Camera On A Maquet Powerled Ii Lighthead

    2. Once the lighthead is turned over, rotate the locking interface anti-clockwise and then remove the camera whilst holding the locking interface Ø The camera has been removed. Fig. 19: Removing a Quick Lock device Maquet Orchide 24 / 50 IFU 04661 EN 04...

  • Page 25: Installing And Removing The Sterilisable Handle

    Removing a sterilisable handle for use with a camera from a lighthead 1. Press the locking button. 2. Remove the handle. Fig. 21: Removing a sterilisable handle for use with a camera Maquet Orchide 25 / 50 IFU 04661 EN 04...

  • Page 26: Fhd Wired Video System

    Video input #2 3G-SD1 video output #2 OTICE If two wired cameras are installed to transmit two separate images, two power ad- apters must be used. Contact the Getinge technical department if necessary. Maquet Orchide 26 / 50 IFU 04661 EN 04...

  • Page 27: Wireless Video System (On Volista Lighthead Only)

    The use of wireless accessories other than those supplied or specified by the manufacturer can affect the operation and performance of the device. Use only the wireless accessories specified by Getinge. OTICE For optimal use of the system, do not use two cameras on the same configuration, and do not position a camera more than 10 m away from its receiver.

  • Page 28: Controlling The Camera

    Adjusting the camera zoom 1. Press Camera Zoom 2. Press Plus or Minus to modify the zoom level. Ø The level indicator varies according to the zoom level setting on the camera. Maquet Orchide 28 / 50 IFU 04661 EN 04...

  • Page 29: Control The Fhd Camera From The Touchscreen Control Panel

    1. Press the Camera pause button to pause the camera. Ø The button is lit blue and the retransmitted image is frozen. 2. Press the Camera pause button again to resume video transmission. Maquet Orchide 29 / 50 IFU 04661 EN 04...
  • Page 30 3. Press the Manual balance button twice to set the white balance on the basis of the tar- get under the camera. Ø The selected button is lit blue and the white balance is applied. Maquet Orchide 30 / 50 IFU 04661 EN 04...
  • Page 31 Adjusting the contrast 1. Press the Contrast button to access the contrast adjustment menu. 2. Press the Increase contrast or Decrease contrast buttons to select one of the three contrast levels. Maquet Orchide 31 / 50 IFU 04661 EN 04...

  • Page 32: Control The 4K Camera From The Touchscreen Control Panel

    1. Press the Camera pause button to pause the camera. Ø The button is lit blue and the retransmitted image is frozen. 2. Press the Camera pause button again to resume video transmission. Maquet Orchide 32 / 50 IFU 04661 EN 04...
  • Page 33 1. Press the Zoom button to access the zoom adjustment menu. 2. Press Zoom in or Zoom out to adjust the size of the image on screen in real time. Fig. 36: Setting the focus Maquet Orchide 33 / 50 IFU 04661 EN 04...
  • Page 34 3. Set one of the zoom values to apply to the selected area 4. Define the corner of the screen in which the wide field image will be transmitted Maquet Orchide 34 / 50 IFU 04661 EN 04...
  • Page 35 1. Switch to the second settings page. 2. Press the Contrast button to access the contrast adjustment menu. 3. Press the Increase contrast or Decrease contrast buttons to select one of the three contrast levels. Maquet Orchide 35 / 50 IFU 04661 EN 04...
  • Page 36 1. Press the Exposure button to access the exposure adjustment menu. 2. Press the Auto Exposure button Ø The button is lit blue and the camera focus is set to automatic. Maquet Orchide 36 / 50 IFU 04661 EN 04...

  • Page 37: Screen Control Interface

    1. Press the Rotate 180° button to rotate the transmitted image 180°. Screen control interface OTICE Refer to the manufacturer's instructions provided with the screen to learn about all the features of the device. Maquet Orchide 37 / 50 IFU 04661 EN 04...

  • Page 38: Troubleshooting

    2. Disconnect and reconnect the receiver power cable 3. Re-register the camera 4. Contact the Getinge tech- nical department Image lost for more than Interference with another sys- 1. The system should reset it- 20 seconds with the OHDII...

  • Page 39: Cleaning / Disinfection / Sterilisation

    (soap solution) containing active substances such as detergents and phosphates. Do not use abrasive products, as these could damage the surfaces. 3. Remove the cleaner using a cloth moistened with water and then wipe with a dry cloth. Maquet Orchide 39 / 50 IFU 04661 EN 04...

  • Page 40: Disinfecting The Device

    ▪ Ethylene diamine tetraacetic acid (2.5%) Tab. 11: Lists of active substances suitable for use Examples of commercially available products tested • ANIOS product®** : Surfa’Safe®** • Other products: 20% or 45% isopropyl alcohol Maquet Orchide 40 / 50 IFU 04661 EN 04...

  • Page 41: Cleaning And Sterilising Maquet Sterigrip Sterilisable Handles

    Typical cleaning cycles in a washer-disinfector The use of non-enzymatic detergents is recommended. Enzymatic detergents may damage the handles. Never soak the handles in these detergents for prolonged periods. Rinse thor- oughly. Maquet Orchide 41 / 50 IFU 04661 EN 04...

  • Page 42: Sterilisation Of The Maquet Sterigrip Handles

    4. Run the sterilisation cycle according to the steriliser manufacturer’s instructions. Sterilisation cycle Temperature Time (°C) (min) (min) ATNC (Prion) ̶ Prevacuum Tab. 13: Example of a steam sterilisation cycle Maquet Orchide 42 / 50 IFU 04661 EN 04...

  • Page 43: Maintenance

    During the guarantee period, maintenance and inspec- tions must be performed by a Getinge technician or a Getinge-approved dealer. After this period, maintenance and inspections may be performed by a Getinge technician, a Getinge-approved dealer or a hospital technician trained by Getinge.

  • Page 44: Technical Specifications

    820 g 790 g Dimensions (diam. x h) (without 93 x 150 mm 129 x 167 mm 132 x 198 mm sterile handle) Tab. 15: Electrical specifications of cameras via touch screen only Maquet Orchide 44 / 50 IFU 04661 EN 04...
  • Page 45 Wired (Coaxial) RS232 interface Weight (without sterile handle) 780 g Dimensions (diam. x h) (without sterile handle) 124 x 181 mm Tab. 16: Technical specifications of the OHDII 4K QL+ VP11 camera Maquet Orchide 45 / 50 IFU 04661 EN 04...

  • Page 46: Other Characteristics

    Medical device classification for Europe, Canada, Korea, Brazil & Australia Class I Medical device classification for USA Class II EMDN code Z12020405 GMDN code 32265 Tab. 20: Specifications relating to standards and regulations Maquet Orchide 46 / 50 IFU 04661 EN 04...

  • Page 47: Emc Declaration

    B defined in CISPR 11 is normally required), this device may not provide sufficient pro- tection for radio frequency communication services. The user may need to take corrective measures, such as relocating or re-orienting the device. Maquet Orchide 47 / 50 IFU 04661 EN 04...
  • Page 48 70% Ut, 500 ms 0% Ut, 5 s Harmonic current emissions EN 61000-3-2 Class A Voltage variations, voltage EN 61000-3-3 Compliant fluctuations, and flicker in pub- lic low-voltage power supply networks Tab. 22: EMC declaration Maquet Orchide 48 / 50 IFU 04661 EN 04...

  • Page 49: Waste Management

    For full information relating to processing of the device once it is no longer in use, see the Maquet Orchide Decommissioning Instructions (ARD04665). Contact your local Getinge representative to obtain a copy of this document. Electrical and electronic components All electrical and electronic components used during the life of the product must be processed in an environmentally friendly manner, in line with applicable local standards.
  • Page 50 *MAQUET POWERLED II, VOLISTA, MAQUET ORCHIDE, MAQUET, GETINGE and GETINGE GROUP are trademarks or registered trademarks of Getinge AB, its divisions or its subsidiaries. **SURFA'SAFE is a trademark or registered trademark of ANIOS Laboratories, its divisions or its subsidiaries. **ANIOS is a trademark or registered trademark of ANIOS Laboratories, its divisions or its subsidiaries.